Dr. Zamboni's multi-center blinded clinical trial begins

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Dr. Zamboni's multi-center blinded clinical trial begins

Postby cheerleader » Sun Jan 16, 2011 9:30 am

Google translate--
link to translated article

STUDY "BRAVE DREAMS": Testing the processing directed by prof. Paolo Zamboni

The Ethics Committee of Ferrara has approved the experimental protocol of randomized controlled trials to evaluate clinical efficacy and safety of the intervention of unblocking the extracranial veins in patients with multiple sclerosis and diagnosis of "chronic cerebrospinal venous insufficiency (CCSVI ) called BRAVE DREAMS.

The trial will involve about 550 patients, about 10-12 clinical centers, with a double-blind procedure.

The study includes a comparison of surgery versus phlebography with venous angioplasty. a control treatment that is only performed phlebography. Eligible patients are aged 18-65 years, with MS defined according to the criteria of McDonald's and with a confirmed diagnosis of CCSVI.

The study has two primary endpoints:
a) clinical (improvement / stability / deterioration in a synthetic functional endpoint) at 12 months
b) MRI (active lesions at 12 months).

The study is intended as a multi-center, with availability in the centers of clinical skills and equipment needed in order to participate in the study. It is expected to recruit about 550 patients. The duration of the planned follow-up is 12 months. Evaluations concerning the follow-up will be conducted in a blinded fashion.

List of centers that sent the request to join the study for experimental angioplasty in patients with MS and CCSVI (study BRAVE DREAMS)
A committee will evaluate the credentials of these centers in making this site known as the Centres have completed the training phase and become operational for the selection of patients who want to join.

Hospital of Busto Arsizio - Milano - Dr. Anthony Tori
Bergamo Hospital - Dr. Rottoli Mariarosa
Cannizzaro Hospital Catania - Dr. Maria Luisa Mandalà
Vicenza Hospital Health Units 6 - Dr. Domenico Soldier
Ospedale Maggiore of Novara of Charity - Dr. Maurizio Leone
Vito Fazzi Hospital of Lecce - Dr. Francesca De Robertis
Hospital - University of Ferrara - Bellaria Hospital in Bologna (Centre National Coordinator. PI Prof Paolo Zamboni) - Dr. Fabrizio Salvi
Local Health Unit of Ravenna - Dr. Fabrizio Rasi
Hesperia Hospital, Modena - Dr. Oscar Maleti
Hospital Valduce Como - Dr. Mario Guidotti
Neurological Institute Carlo Besta of Milan - Dr. Paolo Confalonieri
CRESM University Hospital San Luigi di Orbassano - Torino - Dr. Antonio Bertolotto
Ospedale SS Annunziata Chieti - Prof Alessandra Lugaresi
Azienda Ospedaliera San Salvatore di Pesaro-Marche United Hospitals North - Dr. Cristiana Taus
Provincial Hospital of Macerata - Dr. Eugenio Pucci
University of Trieste - Prof Zorzon Marino
Company ULS 16 of Padova - Dr Giampiero Avruscio
IRCCS Policlinico S. Donato Milano - Prof. Giovanni Meola
AOOR Villa Sofia-Brain-PALERMO - Dr. Salvatore Cottone

What does BRAVE DREAMS?
It literally means BRAVE DREAMS. In reality English is the abbreviation for Brain Venous Drainage Exploited Against Multiple Sclerosis, which translated means "Exploiting the venous drainage of multiple sclerosis."
For the training of legal professionals in the field CCSVI, to contact the point of listening to the Hospital of Ferrara CCSVI
click here: http://www.ccsvi-sm.org/?q=node%2F3
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Dr. Zamboni's multi-center blinded clinical trial begins

Postby Cece » Sun Jan 16, 2011 10:26 am

The study has two primary endpoints:
a) clinical (improvement / stability / deterioration in a synthetic functional endpoint) at 12 months
b) MRI (active lesions at 12 months).

These are very much "MS" endpoints and not "CCSVI" endpoints. I hope that results will show! Multi-center, huge number of patients, Zamboni's involvement, double-blinded, lots of fantastic here. How is he doing for funding?

By the MS endpoints as opposed to CCSVI endpoints, I mean that it sets the bar so high. A low bar might be looking at CCSVI patients who have had venoplasty and those who have not and comparing who has better blood flow! I think we could get definite results showing that CCSVI patients who have had venoplasty have better blood flow that CCSVI patients who have not. Next step up from that is looking at patients who have improvements in the most seemingly CCSVI-related symptoms such as fatigue and weakness that have been seen in cases of cerebral venous obstruction in other diseases (blockage due to dialysis being the most relevant one). I believe Dr. Dake's upcoming three-month trial looks at these sorts of things: symptomatic improvements, QOL. Then this study by Zamboni is of the most ambitious sort, looking for the impact on MS lesions and progression as a result of CCSVI treatment.
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Re: Dr. Zamboni's multi-center blinded clinical trial begins

Postby frodo » Sun Jan 16, 2011 3:23 pm

I think the 12 month endpoint is not a good idea. Maybe 3 or 6 month would be better because:

- lower risk of restenosis. Restenosis cases will hide the possible relationship between MS and CCSVI

- Unknown effects playing a role. A huge number of cases report surprising effects at 3 or 6 months that later dissapear.

I hope that they will at least make a follow-up at 3 or 6 months.
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Postby cheerleader » Sun Jan 16, 2011 4:03 pm

I believe the duration of the blinded follow-up is 12 months, but would imagine there will be check ups in between blinded treatment and end point at regular intervals...but could be wrong on that, guys. If I learn any more, will post on this thread.

Dr. Dake's blinded study has a much shorter end point at 3 months. Dr. Mehta's is one year, Siskin's is 2 years, with 1 month, 6 month, one year, 18 month check-ups and the Hubbard registry is not blinded and has a five year end point, with regular check-ups.
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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby Cece » Sun Jan 16, 2011 4:34 pm

Since they are measuring MS progression and lesions, twelve months is a reasonable amount of time. My understanding is a standard amount of time for MS drug trials has been two years. MS can be slow and chronic and variable, it takes longer to measure changes in a meaningful way. Dr. Cumming has also raised the concern that while placebo has previously been thought to only last a month or two, in studies there are placebo effects shown to still be going all the way to six months, so that would also support the need for a longer trial as tested against placebo.

Here is a fund-raising campaign for Dr. Zamboni's trial:
http://www.facebook.com/photo.php?fbid= ... 0796282297
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Postby MrSuccess » Sun Jan 16, 2011 6:10 pm

lost track after counting 16 new doctors involved in Dr. Zamboni's 550 person CCSVI study. :D

nice way to start a New Year .

This is what is needed. Lot's of variables ..... lot's of data to evaluate .




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great start

Postby hwebb » Mon Jan 17, 2011 3:52 am

I am quitely confident that at least one of these endpoints will show CCSVI favourably.

They are looking for active lesions at 12 months. In my personal case, the IR was only able to rectify one of three stenosed veins at the 3 month point...however this had a huge impact. MRI at the 3 month point indicated zero active lesions - when my MRI was formerly lit up like a x-mas tree and I was being advised by neuro to go off my drugs as they'd caused an increase in my relapse rate and MS activity.

GO TEAM ITALY!
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Is there any new about Grozdinsky?

Postby frodo » Mon Jan 17, 2011 6:13 am

By the way, are there any news about Grozdinsky?

His trial was supposed to last 6 months and he started on April 2010. It should be close to the end, isn't it?
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Postby muse » Tue Jan 18, 2011 7:37 pm

Sief H., MD wrote yesterday on the CCSVI in MS facebook page: http://www.facebook.com/pages/CCSVI-in- ... 0796282297

“I had written to Dr. Grozdinski (Tokuda Hospital, Sofia, Bulgaria) to see where they where at in terms of their research and publications. It looks like something big is going to come out in the next while from the Bulgaria group, who is sitting on the biggest stockpile of clinical information of all the groups. Great ...news!. Here is letter below:

Dear -------:
Thank you for writing us. Yes we are planning to publish our research very soon, we have a lot of experience in CCSVI (more then 700 patients) and we will show the results to the world. If yourself are interested in CCSVI diagnostic and treatment you're welcome to our CCSVI center
regards
Prof. Grozdinski"
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Postby frodo » Wed Jan 19, 2011 3:05 am

muse wrote:Sief H., MD wrote yesterday on the CCSVI in MS facebook page: http://www.facebook.com/pages/CCSVI-in- ... 0796282297

“I had written to Dr. Grozdinski (Tokuda Hospital, Sofia, Bulgaria) to see where they where at in terms of their research and publications. It looks like something big is going to come out in the next while from the Bulgaria group, who is sitting on the biggest stockpile of clinical information of all the groups. Great ...news!. Here is letter below:

Dear -------:
Thank you for writing us. Yes we are planning to publish our research very soon, we have a lot of experience in CCSVI (more then 700 patients) and we will show the results to the world. If yourself are interested in CCSVI diagnostic and treatment you're welcome to our CCSVI center
regards
Prof. Grozdinski"


Wow! thanks
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